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Completed

NCT Number: NCT05750771

Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. older than 60 years of age.
  • 2. meeting the indications for coronary intervention.
  • 3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) ;
  • 4. Target lesion vessel diameter > 2.75 mm

Exclusion criteria

  • 1. inability to provide written informed consent.
  • 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
  • 3. the subject is participating in another uncompleted clinical trial
  • 4. life expectancy <1 year.
  • 5. non-in situ vascular lesions.
  • 6. cardiogenic shock.
  • 7. Patients with hemodynamic instability

Treatment and study plan

DES

Device

Second-generation drug-eluting stents

DCB

Device

Drug-coated balloon with paclitaxel as drug coating

Primary outcomes

  1. LLL

    Time frame: 12 months

    Late lumen loss (LLL) of the target lesion segment

Secondary outcomes

  1. MACE

    Time frame: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge

    Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Official study title

Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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